Various intravascular deliverable devices are used for treating specific conditions via access through body lumina, such as patients circulatory system. The target site may for instance be an atrial or ventricular septum having a defective opening to be occluded, such as devices for treating septal defects and the like. In certain circumstances, it may be necessary to occlude a patient's lumen, vessel, chamber, channel, hole, or cavity such as to stop blood flow there through. One such condition known in the art is a patent ductus arteriosus (PDA), which is essentially a condition wherein two blood vessels, most commonly the aorta and pulmonary artery adjacent the heart, have a blood flow shunt between their lumens. Blood can flow directly between these two blood vessels through the passageway, compromising the normal flow of blood through the patient's vessels. Other physiologic conditions in the body occur where it is also desirous to occlude a vessel, a shunt between vessels, or an ostium at a branch vessel, in order to prevent blood flow through the vessel.
An occlusion device for treatment of such heart disease is disclosed in United States patent application publication number 2009/0187214. A tubular member of a braided fabric is disclosed having disc-shaped portions connected to either side of the tubular member via transition segments having reduced cross-sectional dimension. The device is delivered by a catheter connected to either of the discs. The discs engage with the walls of the septum. The diameter and length of the PDA is determined by angiography in order to select the size of the device, where the latter dimension requirement is a particular issue due to the double disc design, which furthermore is increasing the complexity of the device and the delivery thereof.
EP2014240 discloses a medical device having a cylindrical body portion, a disc portion, and a small transition diameter there between. The transition diameter is recessed within an indention. A problem with the device is lack of flexibility and compactness of the device.
A problem with prior art is to achieve sufficient flexibility while maintaining a compact device. This applies in particular during delivery through tortuous channels. Flexibility is also desired during deliver when releasing the implantable device out of a catheter to the target site. Moreover, a degree of flexibility to accommodate anatomical movements without fatigue or risk of loosening from the implantation site during an ingrowth period is also a desired characteristic of such devices. Further, a compact device is desirable for quick and easy delivery, for example via a catheter, and for occupying less space in the body, thereby reducing chance of interference with bodily functions. A more flexible implant is desired in terms of adjustments of the device used and applied methods, due to the fact that different patients are anatomically slightly different to one another and that the deficiency to be treated is most often individual and unique for each patient treated.
A problem with prior art is to achieve a secure attachment of the device in the body while maintaining ease of delivery. Secure attachment is necessary for patient safety and achieving the intended treatment of the septal defect.
Thus, there is a need for an implant which adjusts for differences in the cardiovascular system between patients still allowing a secure deployment of a medical implant.
Also, a problem with prior art is that delivery of the device via the aorta having a high pressurized blood environment may give rise to several undesired conditions. Debris, e.g. from arteriosclerotic deposits scraped loose by the device under delivery, for instance at ostia of branch vessels, may cause embolic complications. Embolic material could thus be transported to vital organs, e.g. to the brain via the subclavian vessels, and cause blood clots, leading to stroke.
The above problems may have dire consequences for the patient and the health care system. Patient risk is increased.
Hence, an improved implant would be advantageous and in particular allowing for increased flexibility, cost-effectiveness, and/or patient safety would be advantageous. Also, and a method for manufacturing such medical implant would be advantageous.